Free Practice ASQ CMDA Exam Questions 2025

Stay ahead with 100% Free Certified Medical Device Auditor CMDA Dumps Practice Questions

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Total 267 Questions | Updated On: Apr 21, 2025

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Question 1

According to the FD&C Act, if a device is characterized as being life sustaining, what should be classification of this device?

A : Class I

B : Class IIa

C : Class III

D : Class II

Answer: C

Question 2

According to QSIT (Quality System Inspection Technique), ‘medical device reporting’ is a satellite subsystem of which subsystem?

A : Corrective and preventive action

B : Production and process controls

C : Material controls

D : Management controls

Answer: A

Question 3

Which of the following is useful to graphically summarize and display the relative importance of the differences between groups of data?

A : Flowchart

B : Cause and effect diagram

C : Pareto chart

D : Scatter diagram

Answer: C

Question 4

According to EU MDR 2017/745, what is the meaning of the requirement to reduce risks ‘as far as possible’?

A : The reduction of risks as far as possible without considering the benefit-risk ratio

B : The reduction of risks as far as possible even with adversely affecting the benefit-risk ratio

C : The reduction of risks as far as possible without adversely affecting the benefit-risk ratio

D : The reduction of risks as far as possible without considering regulatory compliance risk

Answer: C

Question 5

Which of the following control charts is used to trend continuous data?

A : X-bar chart

B : U chart

C : np chart

D : P chart

Answer: A

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Total 267 Questions | Updated On: Apr 21, 2025

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